Cardiometabolic Efficacy and Renal Safety of Saroglitazar in Indian Patients with Type 2 Diabetes — a 36-Month Retrospective Observational Study

Objective. To evaluate the long-term cardiometabolic efficacy and renal safety of saroglitazar 4 mg once daily in Indian patients with type 2 diabetes mellitus (T2D), stratified by baseline estimated glomerular filtration rate (eGFR), over 36 months. Methods. This retrospective, observational, two-center study analyzed records of 110 adult patients with T2D receiving saroglitazar 4 mg once daily, stratified by baseline eGFR according to Kidney Disease: Improving Global Outcomes (KDIGO) categories (≥ 90 to 15–29.99 mL/min/1.73 m 2 ). Efficacy [fasting blood glucose (FBG), postprandial blood glucose (PPBG), glycated hemoglobin (HbA1c), lipid profile, alanine aminotransferase (ALT), and aspartate aminotransferase (AST)] and safety [body weight, body mass index (BMI), serum creatinine, and eGFR] endpoints were assessed at baseline and 3, 6, 12, 24, and 36 months using repeated-measures analysis of variance (ANOVA) and paired t-tests. Results. The mean age was 54.4 ± 11.9 years; 60.9% were male; the mean baseline eGFR was 86.7 ± 21.3 mL/min/1.73 m 2 . At 36 months, triglycerides decreased by 238.6 mg/dL (−57.1%, p < 0.0001), HbA1c by 1.1% (p < 0.0001), FBG by 44.7 mg/dL (−26.8%, p < 0.0001), total cholesterol by 48.1 mg/dL (−24.2%, p < 0.0001), ALT by 20.7 U/L (−45.4%, p < 0.0001), and AST by 13.1 U/L (−40.4%, p < 0.0001). Body weight (−1.9 kg; p = 0.0732) and serum creatinine (−0.0 mg/dL; p = 0.5409) remained stable, and overall eGFR increased nonsignificantly (+1.2 mL/min/1.73 m 2 ; +1.3%; p = 0.4573), with significant improvements in the 60–89.99 (p = 0.0052) and 45–59.99 (p = 0.0420) strata. Conclusions. In this uncontrolled, retrospective cohort, saroglitazar was associated with sustained improvements in glycemia, atherogenic dyslipidemia (AD), and hepatic enzymes over 36 months, with stable renal function in the cohort with predominantly normal to mildly reduced eGFR cohort. Findings in more advanced chronic kidney disease (CKD) were derived from limited cases and warrant confirmation in larger, prospective studies before extrapolation to moderate-to-severe CKD.